Scientist / Sr. Scientist - Quality Control (QC) Development

Location
Menlo Park, CA
Posted
Jul 29, 2021
Ref
1696178
Required Education
Doctorate/PHD/MD
Position Type
Contract

 

JOIN US!

Adicet Bio, Inc. is a biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer and other diseases. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors and T cell receptor-like antibodies to enhance selective tumor targeting, facilitate innate and adaptive anti-tumor immune response, and improve persistence for durable activity in patients. For more information, please visit our website at http://www.adicetbio.com.

 

Scientist / Sr. Scientist – Quality Control (QC) Development

Adicet Bio is seeking an experienced professional to work in QC and CMC Analytical Operations Department.  In this position, the individual will execute activities both internally and with the company’s external contract manufacturing and contract testing partners for the development, validation and implementation of analytical methods and controls to support product development and commercialization.  The individual will ensure compliance with applicable regulatory and industry standards for phase appropriate development of the company’s products.

 

Key Responsibilities

  • Execute activities to achieve QC and CMC-related analytical objectives enabling the development, manufacture, distribution and delivery of cell-based therapy products, viral vectors and/or monoclonal antibodies.
  • Engaging/ leading in QC method evaluation, optimization, and qualification/validation to enable the characterization, release and stability monitoring of drug substance and drug product.
  • Participate, perform and/or lead analytical method technical transfer to Contract Testing Laboratories (CTL) and Contract Manufacturing Organizations (CMO).
  • Manage and support CTL and CMO analytical activities. Review executed QC test results and reports for product release and disposition, including the investigation and resolution of non-conformance events.
  • Create, compile and review technical and regulatory documents including but not limited to analytical study data summaries and reports, analytical method development reports, method qualification/validation protocols and reports, standard operating procedures in compliance with regulatory requirements.
  • Lead, manage and provide mentorship and scientific guidance to junior staff.

 

Qualifications:

  • Ph.D. degree in Immunology, Cell Biology, or related field is preferred.
  • At least two years (Scientist) or five years (Sr. Scientist) relevant experience in biopharmaceutical or biotechnology industry with a primary focus on QC and/or CMC Analytical Operations is a plus.
  • Experience in CAR-T, gene therapy, cell therapy, vaccine, viral vector, protein-monoclonal antibody in regulated environments is strongly preferred.
  • Expert knowledge of cGMP, comparability protocols and method qualification/validation practices is required.
  • Experience with the set-up, execution and technology transfer of multicolor flow cytometry assays and other analytical QC methods to CMOs is strongly preferred.
  • Experience in ligand-based assays, cell-based assays, immunoassays and compendial methods in regulated environments is a plus.
  • Excellent interpersonal and strong leadership skills with the ability to influence and liaise in a cross-functional team environment.
  • Excellent written and oral communication skills.
  • Self-motivated and detail-oriented, with the highest integrity.
  • Ability to work independently, multitask and meet deadlines in a fast-paced environment.

 

Benefits:

Adicet Bio offers both comprehensive benefits and Paid Time (PTO) plans for employees, which begin on the first day of employment, as well as the opportunity to work in a growing, dynamic environment.

Adicet Bio is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.